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Central Nervous System Clinical Trials: Suicidality and Data Collection - A Workshop

Completed

The Forum on Neuroscience and Nervous System Disorders held a public workshop on June 16, 2009 to examine data collection of suicidality in central nervous system clinical trials. Individuals from the FDA, pharmaceutical industry, academia, NIH, and advocacy groups were invited to make presentations and stimulate discussions focused on how best to integrate the current tools for data collection with current methods of data analysis.

Description

An ad hoc committee will plan and host a public workshop inviting individuals from the FDA, pharmaceutical industry, academia, NIH, and advocacy groups to make presentations and stimulate discussions focused on how best to integrate the current tools for data collection with current methods of data analysis. In addition, the workshop participants will discuss opportunities for potential partnerships with various stakeholders. Specifically, participants will be invited to present and discuss information that will:

  • Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior particularly in the short-term.
  • Ascertain optimal methods of analysis to address if suicidal ideation predicts the short-term occurrence of actual suicidal behavior.
  • Examine potential partnerships between the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data-sharing from randomized clinical trials.

An individually authored summary of the workshop will be prepared in accordance with institutional policy and procedures.

Collaborators

Committee

Robert D. Gibbons

Co-Chair

William Z. Potter

Co-Chair

Charles M. Beasley, Jr.

Member

David A. Brent

Member

Yeates Conwell

Member

Walter J. Koroshetz

Member

Thomas P. Laughren

Member

Husseini K. Manji

Member

David Michelson

Member

Atul C. Pande

Member

Philip S. Wang

Member

Sponsors

Department of Health and Human Services

National Science Foundation

Private: For Profit

Private: Non Profit

Staff

Bruce Altevogt

Lead

Clare Stroud

Lead

Major units and sub-units

Health and Medicine Division

Lead

Institute of Medicine

Lead

Board on Health Sciences Policy

Lead

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